Microarray Assay for Detection of Lab Animal Pathogens

用于检测实验动物病原体的微阵列分析

• 批准号: 7251889
• 负责人: Christopher Sears
• 金额: $ 37.49万
• 依托单位: AMBERGEN, INC
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-04-01 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7251889
• 关键词: Animal Experimentation; Animals; Antigens; Benchmarking; Binding; Biological Assay; Biological Markers; Biomedical Research; Clinical; Compatible; Computer software; Condition; Detection; Development; Devices; Diagnostic; Diagnostic Services; Diarrhea; Environment; Enzyme-Linked Immunosorbent Assay; Evaluation; Feedback; Film; Glass; Goals; Hand; Health; Housing; Immunoassay; Infant; Infection; Laboratories; Laboratory Animals; Medical Surveillance; Mice Minute Virus; Microfluidics; Molecular; Monitor; Murine hepatitis virus; Murine pneumonia virus; Mus; Parvovirus; Performance; Phase; Play; Population; Printing; Purpose; Pyroxylin; Rattus; Reader; Reagent; Recombinants; Research; Role; Ross brand of tetrahydrozoline hydrochloride; Sampling; Sensitivity and Specificity; Series; Serological; Serum; Site; Slide; Staging; System; TMEV; Testing; TimeLine; Toxicology; Universities; VX nerve gas; Validation; animal colony; animal facility; antigen binding; assay development; base; cost; design; drug development; epizootic; expression cloning; high throughput analysis; medical schools; novel; pathogen; prototype; research study; size

DESCRIPTION (provided by applicant): Research animals play a crucial role in biomedical research, drug development and toxicology testing. It is estimated that an average population of over 30 million mice and rats is maintained in the U.S. alone for these purposes. The presence of undetected infections can compromise experiments and/or cause the loss of valuable strains or entire colonies. The goal of this project is to develop a cost-effective microarray-based sero-surveillance system for a comprehensive health assessment of laboratory animals with a special focus on mice. The Murine MonitorTM System will be capable of simultaneously testing for the presence of up to 9 relevant murine pathogens, requiring only 10-20 microliters of serum. During Phase I, several critical components of the Murine MonitorTM have been extensively evaluated including a novel proprietary array substrate and two prototype platforms, demonstrating the feasibility of this approach. During Phase II, our specific aims will focus on: a) expression and validation of recombinant antigens, b) development of a 4-pathogen Surveillance Assay, c) development of a 9-pathogen Surveillance Plus Assay. For both assay panels, the critical assay parameters of sensitivity, specificity and precision will be determined and optimized to meet performance criteria. After internal validation, prototype Murine MonitorTM systems will be placed at two collaborating sites for testing. An ultra-low-cost novel reader aimed at small laboratories consisting of a hand-held reader and associated microfluidic cartridge which is preloaded with reagents will be manufactured for this project by Claros Diagnostics, Inc. Dr. Susan Compton, Chief of the Molecular, Serological and Virological Diagnostics Unit at Yale University School of Medicine and Animal Facility will serve as a consultant and will participate in beta-testing. Dr James Fahey, Chief of Diagnostic Services at The Jackson Laboratory, which houses over 1 million mice, will also participate in beta-testing the Murine Monitor and provide feedback on its performance.

描述（由申请人提供）：研究动物在生物医学研究，药物开发和毒理学测试中起着至关重要的作用。据估计，仅出于这些目的，仅在美国，仅在美国维持了超过3000万小鼠的平均人群。未发现感染的存在会损害实验和/或导致有价值的菌株或整个菌落的丧失。该项目的目的是开发一种基于成本效益的微阵列血清筛性系统，以对实验动物进行全面的健康评估，并特别关注小鼠。鼠Monitortm系统将能够同时测试9种相关的鼠病原体的存在，仅需要10-20微光的血清。在第一阶段，已经对鼠Monitortm的几个关键组成部分进行了广泛的评估，其中包括一种新型的专有阵列底物和两个原型平台，证明了这种方法的可行性。在II阶段期间，我们的具体目标将重点放在：a）重组抗原的表达和验证，b）开发4个病原体监测测定法，c）开发9个病原体监测加上测定法。对于两个测定面板，将确定并优化敏感性，特异性和精度的关键测定参数，以满足性能标准。内部验证后，原型鼠Monitortm系统将放置在两个协作站点进行测试。一个超低成本的小说读者，针对由手持式读取器和相关的微流体墨盒组成的小型实验室，该墨盒将由试剂预装的预装，由Claros Diagnostics，Inc. Susan Compton博士为该项目制造。杰克逊实验室诊断服务的负责人詹姆斯·法伊（James Fahey）博士（杰克逊实验室（Jackson Laboratory）拥有超过100万只小鼠，他还将参与测试鼠监测器的β监测仪，并提供有关其性能的反馈。